Glycaemic Control and Quality of Care in Type 2 Diabetes on NovoMix® 30 Previously Treated With Mixtard® Insulins

NCT00657319 | Completed

• 1 other identifier: BIASP-1939
• Study Type: observational
• Target: 3,495
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is conducted in Europe. The objective of this retrospective observational cohort analysis is to assess the changes of glycaemic control and quality of care in those Type 2 diabetic patients who were previously treated with Mixtard® insulins after 6 months of their switch to analog premix insulin NovoMix® 30 therapy.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1C

  6 months

Secondary Outcomes (1)

• General conditions (reason of switch, BMI, selected laboratory parameters, quality of care)

  6 months

Study Arms (1)

A

Drug: biphasic insulin aspart 30

Interventions

biphasic insulin aspart 30 DRUG

The observation is performed under normal clinical practice conditions without any additionally required diagnostic/therapeutic features. Physicians are allowed to decide the treatment regimen according to the medical standards.

Also known as: NovoMix® 30

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult with type 2 diabetes mellitus on premix insulin treatment.

You may qualify if:

• Subjects diagnosed with type 2 diabetes previously treated with BHI for at least 12 months
• Analogue premix administration for the last 6 months

You may not qualify if:

• Known or suspected allergy to insulin aspart
• Newly diagnosed diabetes

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Budapest, 1025, Hungary

Location

Related Publications (1)

• Gerö L. Improvement in metabolic control in type 2 diabetic patients after switching from biphasic human insulin (BHI) to biphasic insulin aspart 30/70 (BIAsp 30): An observational study in Hungary. ADA American Diabetes Association 2009; Country: USA City: New Orleans

  RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: April 1, 2008
• Last Updated: January 9, 2017

Record last verified: 2017-01

Locations

HU (1)